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A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension
Recruiting
Trial ID: NCT06034743
Purpose
This is a Phase III, multicentre, randomised, double-blinded, placebo-controlled, parallel
group study to evaluate the safety, tolerability and effect of 1 or 2 mg baxdrostat versus
placebo, administered once daily (QD) orally, on the reduction of systolic blood pressure in
approximately 720 participants aged ≥ 18 years with hypertension, despite a stable regimen of
2 antihypertensive agents at baseline, one of which is a diuretic (uncontrolled
hypertension); or ≥ 3 antihypertensive agents at baseline, one of which is a diuretic
(treatment-resistant hypertension).
Official Title
A Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension
Stanford Investigator(s)
Vivek Bhalla, MD
Associate Professor of Medicine (Nephrology)
Eligibility
Inclusion Criteria:
- Male or female participants must be ≥ 18 years old
- Mean sitting systolic blood pressure on automated office blood pressure measurement ≥
140 mmHg and < 170 mmHg at Screening
- Fulfil at least 1 of the following 2 criteria:
1. uHTN subpopulation: have a stable regimen of 2 antihypertensive medications, from
different therapeutic classes (at least one should be a diuretic), at maximum
tolerated dose in the judgement of the Investigator
2. rHTN subpopulation: have a stable regimen of ≥ 3 antihypertensive medications,
from different therapeutic classes (at least one should be a diuretic), at
maximum tolerated dose in the judgement of the Investigator
- Estimated glomerular filtration rate ≥ 45 mL/min/1.73m2 at Screening
- Serum potassium (K+) level ≥ 3.5 and < 5.0 mmol/L at Screening
- Randomisation Criterion:
- Sitting systolic blood pressure on attended automated office blood pressure
measurement of ≥ 135 mmHg at baseline
Exclusion Criteria:
- Mean sitting systolic blood pressure on attended automated office blood pressure
measurement ≥ 170 mmHg at Randomisation
- Mean seated diastolic blood pressure on attended automated office blood pressure
measurement ≥ 110 mmHg at Randomisation
- Serum sodium level < 135 mmol/L at Screening
- Has the following known secondary causes of hypertension: renal artery stenosis,
uncontrolled or untreated hyperthyroidism, uncontrolled or untreated hypothyroidism,
pheochromocytoma, Cushing's syndrome, aortic coarctation
- New York Heart Association functional heart failure class IV at Screening
- Persistent atrial fibrillation
Intervention(s):
drug: Baxdrostat
drug: Placebo
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305